N/A 227522

GUDID 04048551279472

FISCH Titanium Neomalleus Prosthesis, 1.1 x 5 mm

Karl Storz GmbH & Co. KG

Ossicular prosthesis, partial
Primary Device ID04048551279472
NIH Device Record Key62a9042e-af87-4df3-bf1b-bb51eed9a449
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number227522
Catalog Number227522
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com
Phone424-218-8201
Emailsu.chen@karlstorz.com

Device Dimensions

Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter
Width1.1 Millimeter
Length5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551279472 [Primary]

FDA Product Code

ETAReplacement, Ossicular Prosthesis, Total

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-10-21
Device Publish Date2015-10-09

On-Brand Devices [N/A]

040485514465840915612-06
04048551441909C-MAC Videolaryngoskop MAC #3
04048551279540FISCH Titanium Stapes Piston, 0.4 x 7 mm
04048551279502FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 3 mm
04048551279496FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 4 mm
04048551279489FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 5 mm
04048551279472FISCH Titanium Neomalleus Prosthesis, 1.1 x 5 mm
04048551279465FISCH Titanium Stapes Piston, 0.4 x 8.5 mm
04048551279458FISCH Titanium Stapes Piston, 0.4 x 10 mm
04048551279441FISCH Titanium Total Prosthesis with Foot, 0.6 x 10 mm

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